MAUDE Adverse Event Report: WARSAW ORTHOPEDICS PRESTIGE CERVICAL DISC SYSTEM; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number 6972470

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Unspecified Infection (1930); Discomfort (2330); Neck Pain (2433); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

Levels involved: c4-5 it was reported that on an unknown date, post-op, patient was suffering from same pain as pre-op left neck pain (no radicular symptoms pre-op only localized pain).Reportedly, "new pain center of neck increased so severely.Patient has occipital head pain.Surgeon stated that the position of the device looked great-no indication of the device misalignment was observed.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that on an unknown date, post-op, patient experienced worsening of symptoms.Patient also developed new symptoms with occipital headaches and cervical pain.Patient underwent brain mri and ct and x-rays flexion and extension which revealed no abnormality.Allegedly the patient could not longer raise her arms or ride in a car.

Event Description

Additional information received from manufacturer representative that patient suffered severe pain and had some allergies.Surgeon had inserted a prestige lp at c4-5 in 2017.Patient went to 3 other surgeons who stated the device was the wrong size (too big) and that she did not meet criteria for the lp procedure anyway.When a surgeon removed lp, it fell apart and had done damage to her vertebrae.Then another physician performed a 2-level surgery c4-5 and c3-4 with a corpectomy and cadaver bone and ¿atlantis plate¿ and screws.Patient requested the composition of these products as she felt some allergies.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PRESTIGE CERVICAL DISC SYSTEM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6953911
• MDR Text Key: 89455474
• Report Number: 1030489-2017-02203
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P090029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Catalogue Number: 6972470
• Device Lot Number: 0361595W
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 11/01/2017; 09/17/2020
• Supplement Dates FDA Received: 11/28/2017; 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other